S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who have never smoked.
Drug: erlotinib hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas|
- Overall survival [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: No ]
- Response rate (complete and partial) [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: Erlotinib and Bevacizumab||Biological: bevacizumab Drug: erlotinib hydrochloride|
- Assess overall survival of patients with stage IIIB or IV primary non-small cell lung adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and bevacizumab.
- Assess progression-free survival of patients treated with this regimen.
- Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset of patients with measurable disease treated with this regimen.
- Evaluate the frequency and severity of toxicities associated with this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445848
Show 153 Study Locations
|Study Chair:||Howard L. West, MD||Swedish Cancer Institute at Swedish Medical Center - First Hill Campus|